Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control

AstraZeneca213 enrolled

Overview

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult Indian patients with inadequate glycaemic control with diet and exercise.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

213

Conditions

Type 2 Diabetes

Interventions

SaxagliptinDRUG

Oral tablet, once daily for 24 weeks

PlaceboDRUG

Oral tablet, once daily for 24 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with Type 2 diabetes * Patients should be drug naïve ie, not received medical treatment for diabetes * HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization) Exclusion Criteria: * Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes) * Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma

Locations (9)

Research Site

Gujarat, Ahmedabad, India

Research Site

Karnataka, Bangalore, India

Research Site

Tamil Nadu, Chennai, India

Research Site

Tamil Nadu, Coimbatore, India

Outcomes

Primary Outcomes

Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)

Adjusted\* mean change from baseline in glycosylated haemoglobin A1c (HbA1c) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.

Time frame: Baseline , Week 24

Secondary Outcomes

Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)

Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.

Time frame: Baseline , Week 24

Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24

Proportion of participants (expressed in percentage of total participants)achieving HbA1c \< 7.0% for saxagliptin versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c data were excluded on and after rescue medication

Time frame: Baseline , Week 24

Data from ClinicalTrials.gov

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